ENS 57935
ENS Event | |
|---|---|
05:00 Sep 8, 2025 | |
| Title | Contamination Detected in Shipping Vial |
| Event Description | The following information was provided by the Illinois Emergency Management Agency (the Agency) via email:
The Agency was contacted on September 8, 2025, by Bard Brachytherapy in Carol Stream, Illinois, to advise that they had detected contamination in a shipment of (72) TheraSeed Model 200 Pd-103 brachytherapy seeds. This is the second shipment of brachytherapy seeds since August, 2025, in which contamination was identified. The first occurrence identified contamination within the shipping vial and no leaking seeds. That occurrence failed to meet reportable criteria. Both shipments had been received directly from the manufacturer, Theragenics, in Georgia. The contamination did not result in any public or occupational exposures, nor were the licensee's facilities contaminated. However, based on additional information provided on September 11, 2025, this matter is reportable to the Agency under 32 Ill. Adm. Code 340.1230(a)(3)(A), the State's equivalent of 10 CFR 20.2203(a)(3)(i). The seeds have been returned to the manufacturer for investigation and to determine if a seed was leaking or there is a repeat instance of a contaminated shipping vial. Details: The shipment consisted of (72) sources at 1.55 millicuries each, for a total consignment of 267.3 millicuries. The brachytherapy seeds are TheraSeed model 200's, under registry number NR-0645-S-101-S. Upon receipt and transfer of brachytherapy seeds to a sterile area, the Illinois licensee surveys the empty shipping vial. It is in this step they identified contamination, later quantified to be approximately 0.013 microcuries. The reportability stems from the fact their license requires testing for contamination prior to incorporating the sources into an implanting device. The reporting threshold is 0.005 microcuries, and thus, this represented the presence of contamination in a restricted area breaching an applicable limit in the license. It is noteworthy a previous incident reported to the Agency on August 21, 2025, also found contamination in a shipping vial, although it did not exceed 0.005 microcuries. The Georgia program was contacted and notified of the incident as well. The licensee met applicable reporting timelines. This report will be updated with any additional information provided by the manufacturer. Item Number: IL250039
The following information was provided by the Illinois Emergency Management Agency and Office of Homeland Security via email: Update: On 10/21/25, Bard received investigation results from Theragenics which did not confirm if the sources were determined to have been leaking but did state that they concluded that the likely root cause for the contaminated vials was from insufficiencies in the production process. Theragenics also stated their intent to improve the 'transferring of seeds' and 'additional seed swipes' steps in their process. Retraining of staff on seed swiping and visual inspection was also to be conducted. This matter may be considered closed pending additional information. Notified R3DO (Ziolkowski) and NMSS Events Notifications (email). |
| Where | |
|---|---|
| Bard Brachytherapy Carol Stream, Illinois (NRC Region 3) | |
| License number: | IL-02062-01 |
| Organization: | Illinois Emergency Mgmt. Agency |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+223.77 h9.324 days <br />1.332 weeks <br />0.307 months <br />) | |
| Opened: | Gary Forsee 12:46 Sep 17, 2025 |
| NRC Officer: | Josue Ramirez |
| Last Updated: | Oct 29, 2025 |
| 57935 - NRC Website
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Bard Brachytherapy with Agreement State | |
WEEKMONTHYEARENS 580442025-11-18T18:18:00018 November 2025 18:18:00
[Table view]Agreement State Lost Sources ENS 579352025-09-08T05:00:0008 September 2025 05:00:00 Agreement State Contamination Detected in Shipping Vial ENS 576972025-05-07T05:00:0007 May 2025 05:00:00 Agreement State Missing Packages ENS 571932024-06-25T05:00:00025 June 2024 05:00:00 Agreement State Broken Brachytherapy Seed ENS 571272024-05-13T05:00:00013 May 2024 05:00:00 Agreement State Lost Brachytherapy Seed ENS 563412023-02-06T06:00:0006 February 2023 06:00:00 Agreement State Lost Brachytherapy Seeds ENS 561812022-10-25T05:00:00025 October 2022 05:00:00 Agreement State Lost Shipments ENS 561452022-09-30T05:00:00030 September 2022 05:00:00 Agreement State Lost Shipment ENS 560832022-08-31T05:00:00031 August 2022 05:00:00 Agreement State Lost I-125 Brachytherapy Seeds ENS 560992022-08-23T05:00:00023 August 2022 05:00:00 Agreement State Loss of I-125 Brachytherapy Seed ENS 560112022-06-29T05:00:00029 June 2022 05:00:00 Agreement State Lost Sources ENS 559512022-06-16T21:00:00016 June 2022 21:00:00 Agreement State Shipment Lost Then Found ENS 538732019-02-13T06:00:00013 February 2019 06:00:00 Agreement State Agreement State Report - Report of Loss of Brachytherapy Seeds ENS 429842006-11-10T06:00:00010 November 2006 06:00:00 Agreement State Shipment of Iodine - 125 Seeds Lost in Transit ENS 411592004-10-29T05:00:00029 October 2004 05:00:00 Agreement State Agreement State Report 2025-09-08T05:00:00 | |